Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) (CE-AF)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PVI with PVAC gold
PVI with Cooled-RF
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, cerebral embolism, catheter ablation
Eligibility Criteria
Inclusion Criteria:
- suffering from drug-refractory paroxysmal atrial fibrillation
- scheduled for first ablation procedure
Exclusion Criteria:
- contra-indications for DW-MRI
- previous AF-ablation
- minors
- any patient unable to undergo neuropsychological testing due to mental retardation
Sites / Locations
- Leiden University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PVI with PVAC gold
PVI with Cooled-RF
Arm Description
Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention.
Patient for pulmonal vein isolation using the Cooled-RF catheter.
Outcomes
Primary Outcome Measures
Cerebral embolism
Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation.
Secondary Outcome Measures
Neuropsychological functioning
A decrease in neuropsychological functioning will be assessed with a questionnaire before and after the procedure
Rise in procoagulation
The procoagulant state will be assessed before, during and after the procedure by measurement of markers of endothelial damage, markers of activated coagulation, markers of fibrinolysis and by measurement of APTT, PT-INR, fibrinogen and thrombin generation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01361295
Brief Title
Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)
Acronym
CE-AF
Official Title
The Occurrence of Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) Using Two Different Ablation Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Serge A. Trines
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation.
Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased.
The goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI.
Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.
Detailed Description
A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing.
Before the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure.
Documentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires.
Finally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, cerebral embolism, catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVI with PVAC gold
Arm Type
Active Comparator
Arm Description
Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention.
Arm Title
PVI with Cooled-RF
Arm Type
Active Comparator
Arm Description
Patient for pulmonal vein isolation using the Cooled-RF catheter.
Intervention Type
Procedure
Intervention Name(s)
PVI with PVAC gold
Other Intervention Name(s)
Medtronic AF solutions
Intervention Description
Pulmonary vein isolation using the Medtronic PVAC gold catheter
Intervention Type
Procedure
Intervention Name(s)
PVI with Cooled-RF
Other Intervention Name(s)
CARTO3 system
Intervention Description
Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter
Primary Outcome Measure Information:
Title
Cerebral embolism
Description
Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation.
Time Frame
Between 24 hours before the ablation and 24 hours after the ablation
Secondary Outcome Measure Information:
Title
Neuropsychological functioning
Description
A decrease in neuropsychological functioning will be assessed with a questionnaire before and after the procedure
Time Frame
Between a week before the ablation until 3 months after the ablation
Title
Rise in procoagulation
Description
The procoagulant state will be assessed before, during and after the procedure by measurement of markers of endothelial damage, markers of activated coagulation, markers of fibrinolysis and by measurement of APTT, PT-INR, fibrinogen and thrombin generation.
Time Frame
Between 24 hours before the ablation and 24 hours after the ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suffering from drug-refractory paroxysmal atrial fibrillation
scheduled for first ablation procedure
Exclusion Criteria:
contra-indications for DW-MRI
previous AF-ablation
minors
any patient unable to undergo neuropsychological testing due to mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge A. Trines, MD, PhD
Organizational Affiliation
Cardiology, LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19549035
Citation
Sauren LD, VAN Belle Y, DE Roy L, Pison L, LA Meir M, VAN DER Veen FH, Crijns HJ, Jordaens L, Mess WH, Maessen JG. Transcranial measurement of cerebral microembolic signals during endocardial pulmonary vein isolation: comparison of three different ablation techniques. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1102-7. doi: 10.1111/j.1540-8167.2009.01509.x. Epub 2009 Jun 22.
Results Reference
background
PubMed Identifier
19933517
Citation
Schrickel JW, Lickfett L, Lewalter T, Mittman-Braun E, Selbach S, Strach K, Nahle CP, Schwab JO, Linhart M, Andrie R, Nickenig G, Sommer T. Incidence and predictors of silent cerebral embolism during pulmonary vein catheter ablation for atrial fibrillation. Europace. 2010 Jan;12(1):52-7. doi: 10.1093/europace/eup350.
Results Reference
background
PubMed Identifier
15133367
Citation
Bulava A, Slavik L, Fiala M, Heinc P, Skvarilova M, Lukl J, Krcova V, Indrak K. Endothelial damage and activation of the hemostatic system during radiofrequency catheter isolation of pulmonary veins. J Interv Card Electrophysiol. 2004 Jun;10(3):271-9. doi: 10.1023/B:JICE.0000026924.96281.be.
Results Reference
background
PubMed Identifier
30898234
Citation
Kece F, Bruggemans EF, de Riva M, Alizadeh Dehnavi R, Wijnmaalen AP, Meulman TJ, Brugman JA, Rooijmans AM, van Buchem MA, Middelkoop HA, Eikenboom J, Schalij MJ, Zeppenfeld K, Trines SA. Incidence and Clinical Significance of Cerebral Embolism During Atrial Fibrillation Ablation With Duty-Cycled Phased-Radiofrequency Versus Cooled-Radiofrequency: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2019 Mar;5(3):318-326. doi: 10.1016/j.jacep.2018.11.008. Epub 2018 Dec 26.
Results Reference
derived
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Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)
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